Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

NCT04626505 | Completed Phase 2 Results

• 3 other identifiers: NN6018-4776U1111-1260-3695jRCT2031200216
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad effects of inflammation on heart disease. Participants will be randomly (by chance) assigned to receive either ziltivekimab or placebo. The chance that participants will be assigned into one of the three study arms of ziltivekimab (either 15 mg or 30 mg) or placebo is the same (approximately 33%). This is a double-blind study, which means neither participants nor the study doctor will know which group the participants are in. In case of an emergency, however, the study doctor can get this information. The study drug will be injected under the skin once every 4 weeks. In this study participants will receive 3 injections of study drug. The total study duration for each participant will be approximately 6 months.

Conditions

Chronic Kidney Disease; Inflammation; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) Levels From Baseline (Average of All Hs-CRP Values Prior to the Administration of Study Drug) to the End of Treatment (Average of Week 10 and Week 12)

  Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.

  Baseline (day 1), end of treatment (average of week 10 and week 12)

Secondary Outcomes (26)

• Number of Treatment-emergent Adverse Events (TEAEs)

  From randomization (Day 1) to week 20

• Number of Serious Adverse Events (SAEs)

  From randomization (Day 1) to week 20

• Number of Participants With Vital Signs Parameters Exceeding Pre-defined Criteria

  From randomization (Day 1) to week 20

• Change in Electrocardiogram (ECG)

  Baseline (Day 1), Week 20

• Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase (LDH) and Lipase Pancreatic

  Baseline (Day 1), Week 20

Study Arms (3)

Ziltivekimab 15 mg

EXPERIMENTAL

Participants will receive ziltivekimab 15 mg for 12 weeks.

Drug: Ziltivekimab

Ziltivekimab 30 mg

EXPERIMENTAL

Participants will receive ziltivekimab 30 mg for 12 weeks.

Drug: Ziltivekimab

Placebo (ziltivekimab)

PLACEBO COMPARATOR

Participants will receive placebo (ziltivekimab) for 12 weeks.

Drug: Placebo (ziltivekimab)

Interventions

Ziltivekimab DRUG

Administered subcutaneously (s.c., under skin) once every 4 weeks for 12 weeks

Ziltivekimab 15 mg; Ziltivekimab 30 mg

Placebo (ziltivekimab) DRUG

Administered s.c. once every 4 weeks for 12 weeks

Placebo (ziltivekimab)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or above 20 years at the time of signing the Informed Consent Form
• Stage 3 to 5 non-dialysis-dependent chronic kidney disease (NDD-CKD), ie, estimated glomerular filtration rate above 10 and below 60 mL/min/1.73 m\^2 using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation
• Serum hs-CRP level equal to or above 2.0 mg/L measured during the screening period. Note: Targeting patients with a history of advanced stage CKD, atherosclerotic cardiovascular disease, anemia, diabetic retinopathy, obesity, or elevated BMI, and diabetes for screening will help increase the chances of identifying patients with hs-CRP equal to or above2.0 mg/L 4. The patient agrees to comply with
• The patient agrees to comply with the contraception and reproduction restrictions of the study as follows:
• Women of childbearing potential must be using a method of contraception that is "highly effective" (ie, less than 1% failure rate) for at least 3 months following the last dose of study drug;
• Postmenopausal women must have had no menstrual bleeding for at least 1 year before initial dosing and either be over the age of 60 years or have an elevated plasma follicle stimulating hormone level (ie, above 40 mIU/mL) at screening;
• Women of childbearing potential must have a documented negative serum pregnancy test result at screening; and
• All male patients, from the day of dosing until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male patients with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) to prevent pregnancy and drug exposure of a partner, and refrain from donating sperm or fathering a child; and
• The patient must be willing and able to provide informed consent and abide all study requirements and restrictions.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in the study:
• Laboratory values
• Absolute neutrophil count below 2.0 × 10\^9/L during screening;
• Platelet count below 120 × 10\^9/L during screening;
• Spot urine protein-creatinine ratio above 4000 mg/g (4.0 g/g) during screening;
• Alanine aminotransferase or aspartate aminotransferase above 2.5 × upper limit of normal during screening;
• Positive testing for tuberculosis during screening. blood testing (eg, QuantiFERON) is preferred, but a purified protein derivative (PPD) skin test read within 48 to 72 hours by a qualified healthcare professional may also be performed. If a patient is PPD positive but QuantiFERON negative, the patient is eligible;
• Evidence of human immunodeficiency virus (HIV)-1 or HIV-2 infection by serology measured during screening;
• Hepatitis B or C by serology (eg, hepatitis B surface antigen or hepatitis C antibody positive) measured during screening;
• Medical conditions or diseases
• Expected to require blood transfusion within 12 weeks post-randomization;
• Thromboembolic event within 12 weeks prior to randomization;
• Clinical evidence or suspicion of active infection;
• History of peptic ulcer disease or gastrointestinal ulceration in the 12 months prior to randomization;
• History of active diverticulitis in the 12 months prior to randomization;

Sponsors & Collaborators

• Novo Nordisk A/S: lead
• Sponsor: Corvidia Therapeutics Inc, a subsidiary of Novo Nordisk A/S: collaborator

Study Sites (1)

Ehime Medical Center

Ehime, 791-0281, Japan

Location

Related Publications (1)

• Wada Y, Jensen C, Meyer ASP, Zonoozi AAM, Honda H. Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial. J Cardiol. 2023 Oct;82(4):279-285. doi: 10.1016/j.jjcc.2023.05.006. Epub 2023 May 19.

  PMID: 37211246 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

ziltivekimab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 12, 2020
• Study Start: October 22, 2020
• Primary Completion: August 3, 2021
• Study Completion: September 28, 2021
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)